Effect of Educatıon Gıven To Patıents Wıth Ureteral Stent (Dj) Insertıon On Postoperatıve Symptom Management And Qualıty of Lıfe

November 28, 2024 updated by: Muazzez Merve TORAMAN, Ataturk University
The data of the randomized controlled experimental study were collected at the Urology Clinics of Atatürk University Health Practice and Research Hospital between April and November 2022. The study sample consisted of 162 patients (82 in the training group, 80 in the control group) who were selected by simple random sampling method and met the inclusion criteria for the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ureteral stents have been widely used in many urological procedures since their use was published by Zimskind in 1967 and Finley's use of the modern double J (DJ) stent in 1978. Ureterorenoscopy (URS) is a popular method used frequently in the diagnosis and treatment of ureteral diseases today. Apart from being performed for diagnostic purposes, URS is most commonly used to treat ureteral stones. The vast majority of ureteral stones are treated endoscopically. A Double-J (DJ) stent is often placed after ureterorenoscopy. The purpose of the stent is to prevent obstruction, renal colic, and deterioration of renal function. The fact that the DJ stent will remain in the patient for a certain period of time (approximately 3-4 weeks) causes anxiety in the patient. However, urinary system symptoms that impair the quality of life are observed in approximately 80% of patients who have a DJ stent. These symptoms include frequent urination (50-60%), urgency (57-60%), pain during urination (40%), incomplete voiding (76%), flank pain (19-32%), suprapubic pain (30%), incontinence and hematuria (25%). In addition, 32% of patients with DJ stents develop sexual dysfunction. 2,3,4 Patients who have DJ stents inserted after ureteroscopy surgery need more information, support, explanation and help to cope with the effects of these symptoms in the clinic and at home. 5 In this context, it is important to provide individualized and comprehensive education that includes the home care process before and after URS. It has been determined in the literature that education given before surgical intervention reduces anxiety, pain level, complication rate and depression rate in the postoperative period and increases patient satisfaction. 6,7,8 However, it is reported that individuals should be discharged with sufficient theory and practice to meet their post-discharge care needs. Although all healthcare personnel are responsible for the discharge education of individuals and their relatives, the most important responsibility belongs to nurses.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 2500
        • Muazzez Merve TORAMAN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Volunteering to participate in the study
  • Having URS surgery for the first time due to stones and temporary DJ stent placement

Exclusion Criteria:

  • Having URS surgery for reasons other than stones
  • Having a permanent stent
  • Having major hearing and vision impairment
  • Using antidepressants or anxiolytics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Patient Education Booklet
Patients will be informed about URS, DJ stents and possible problems in the early postoperative period with an education booklet and the patient's questions will be answered.
Procedure: Patient Education Booklet
Before the surgery, a personal information form and the SF-36 Quality of Life Scale will be filled out. The educational content regarding the problems that these patients may encounter with the DJ stent after the surgery until they are discharged will be explained in sections and the patients' questions will be answered. When the patient comes to the hospital for DJ stent removal 4 weeks after discharge, the Ureteral Stent Symptom 1st Questionnaire and the SF-36 Quality of Life Scale will be filled out while the DJ stent is in place. The Ureteral Stent Symptom 2nd Questionnaire and the SF-36 Quality of Life Scale will be applied 4 weeks after the stent is removed. The education booklet will be prepared by the researchers in accordance with the recommendations of the European Association of Urology and the relevant literature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: The universe of the study, between April and November 2022.
Ureteral Stent Symptom Questionnaire: In 2003, Joshi and colleagues developed a special questionnaire for the assessment of quality of life and stent-related symptoms. The Ureteral Stent Symptoms Questionnaire (USSQ), a validated tool that assesses symptoms and quality of life, was validated in Turkish by Yılören and colleagues in 2017. The USSQ was originally designed as a 38-item questionnaire with 33 Likert-type questions and 5 more descriptive items organized into six main areas. This questionnaire provides a comprehensive assessment of urinary symptoms, general health, pain, sexual health, work performance, and other additional problems related to ureteral stents
The universe of the study, between April and November 2022.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

November 28, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Muazzez Merve TORAMAN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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